Page 4 - Quality control of pharmaceuticals (07-PA 704) practical
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❖ Main Microbiological test methods:
o Sterility testing: for sterile drugs like: eyedrops and injectables.
o Microbial limit test: for all kind of oral drugs and superficial ointments and their
raw materials.
o Bioburden testing: production rooms, Laminar air flows, sterility testing room,
other test rooms, sampling room, sampling booths etc.
o Water testing: water used for production.
❖ Basic definitions
o Isolation: Pure culture (plate culture at general purpose non inhibitory media like
nutrient agar, soybean casein digest agar etc
o Identification: gram stain/ selective media depending upon colony
characteristics: if gram positive cocci in clusters; indicative to Staphylococcus sps
: Manitol salt agar/ biochemical tests : catalase/ coagulase
o Preservation ( if necessary) : preserved at 2-8 ºC
o Destruction/ Disposal: Autoclaved at 121 ºC at 15 lbs pres sure for 15 minutes /
autoclaved media with organisms buried into a pit.
o MLT: Microbial limit test
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